Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial.

BACKGROUND: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. STUDY DESIGN: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. SUMMARY: This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.

Detecting the association between residual thrombus and post-thrombotic classification of chronic venous disease with range regression.

This paper addresses a clinical hypothesis detected by the method of range regression, a new statistical method portraying the clinical response via the range of an explanatory variable. For patients with iliofemoral deep venous thrombosis, it has long been clinically suspected that residual thrombus affects the quality of life after catheter-directed thrombolysis. However, such important medical experience has not been validated or scientifically quantified by experimental or observational data. In clinical practice, this association may directly affect the duration of thrombolytic therapy or other attempts at clot removal. In this study, we develop a new regression model to identify how the quantity of clot lysed affects the clarification of chronic venous disease after catheter-directed thrombolysis (a correlated index on postthrombotic quality of life). Bridging clinical insight with statistics by means of medical records of 62 IFDVT patients, the new method reveals that residual thrombus significantly and substantially affects post-thrombotic clarification of chronic venous disease. The conclusion of the new method is confirmed by a conventional logistic regression method when 50% thrombus removal is treated as a categorization threshold. This new approach is applicable to analyze other clinical or medical variables on the treatment of venous diseases.